This section introduces aspects that may help facilitate a better understanding of the disclosure. Accordingly, these statements are to be read in this light and are not to be understood as admissions about what is or is not prior art.
Health care providers administering medications to patients must exercise great care in determining the amount medication to inject into the patient's body. Similarly, for example, diabetic patients must likewise take great care to ensure the amount of insulin injected into their bodies is of the appropriate dosage. Unfortunately, however, many patients suffer ailments (e.g., failing eyesight) that make it difficult, and often dangerous, to adequately administer the required dosage of medication into their bodies. Such consequences can be extended to all drugs that must be administered via a syringe. Given that an improper dosage can result in serious consequences, it is critical that both health care providers and patients themselves be able to clearly and accurately determine the amount of medications loaded in a syringe prior to injection.
Additionally, health care providers and patients themselves who must administer a drug via a syringe continually face the risk of accidental needle sticks. Even when cautious, there is always a chance that the person administering the drug via a needle syringe will slip and accidentally stick himself or another person. Every year in the United States, 44,000 to 98,000 people die as a result of medical error. Medication errors are a leading form of medical harm with over 1.5 million adverse drug events associated with medication use occurring every year. The medication use process is complex and difficult to navigate, even for trained professionals. Some medications are more prone to error than others for patients and professionals alike, and these medications earn the title high risk medications. Every year without fail, more errors associated with injectable insulin are reported than any other medication. This is exceptionally troubling given the nature of the medication insulin. It is an endogenous hormone in the human body that we supplement for patients with diabetes who do not synthesize sufficient quantities or for those who have developed an insensitivity to insulin in their body. Small volumes of insulin, measured and dosed to patients in terms of units of insulin, can have profound effects on our bodies. Volumes as small as 10 units or less can be enough to send someone into a state of hypoglycemia, a condition that if uncorrected can have dramatic effects and in some instances, if not reversed, be fatal. This range between where the medication is useful to patients and the point at which it becomes toxic is known as a therapeutic window. Insulin has one of the narrowest therapeutic windows but one of the widest ranges of dosing as patients can require as little as 2 units and some could require over 100 units.
Combined with the narrow therapeutic window of insulin, we additionally complicate this process by manufacturing more than one concentration of insulin. Currently, 100 unit/mL and 500 unit/mL concentrations are readily available with a 200 unit/mL concentration available in the EU that may someday soon be available in the United States. Administering these doses requires drawing insulin up into an insulin syringe, which is a device specifically designed and marked for volumes of 100 unit/mL insulin. Therefore, a patient needing to administer 16 units could draw up precisely this amount into their syringe from a multi-dose vial and administer it to themselves. Patients that receive more than 200 units of insulin per day may elect to be placed on U500 (500 unit/mL insulin) to minimize the volume of fluid injected daily. In order to perform this process, these patients still must use a U100 (100 unit/mL) insulin syringe to accomplish this task.
Thus, there remains an unmet need for syringes that enable safe, reliable administration of a drug to protect against both improper dosage and inadvertent needle sticks.